OBJECTIVE: To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL). DESIGN: Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene gel. SETTING: Three university-based clinics. PARTICIPANTS: Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL. INTERVENTIONS: Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose. MAIN OUTCOME MEASURES: Patients were followed for efficacy and safety, and treatment continued as long as they benefited. Response (> or =50% improvement) was evaluated by the Physician's Global Assessment of cutaneous disease and by an overall severity assessment of cutaneous disease, including signs of CTCL and area involved. RESULTS: Most patients tolerated topical bexarotene at 1% gel twice daily for routine use. Adverse events were generally mild to moderate in severity and were confined to treatment sites. Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure. Patients achieved an overall response rate of 63% and a clinical complete response rate of 21%. Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks. Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%). CONCLUSIONS: Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.
OBJECTIVE: To evaluate the safety, dose tolerance, and efficacy of topical bexarotene gel in patients with early-stage cutaneous T-cell lymphoma (CTCL). DESIGN: Phase 1 and 2, open-label, dose-escalation clinical trial of bexarotene gel. SETTING: Three university-based clinics. PARTICIPANTS: Sixty-seven adults with early-stage (TNM stages IA-IIA) CTCL. INTERVENTIONS:Bexarotene gel, 0.1%, 0.5%, and 1.0%, applied in incremental dose adjustments from 0.1% gel every day to 1.0% gel 4 times daily or the maximal tolerated dose. MAIN OUTCOME MEASURES: Patients were followed for efficacy and safety, and treatment continued as long as they benefited. Response (> or =50% improvement) was evaluated by the Physician's Global Assessment of cutaneous disease and by an overall severity assessment of cutaneous disease, including signs of CTCL and area involved. RESULTS: Most patients tolerated topical bexarotene at 1% gel twice daily for routine use. Adverse events were generally mild to moderate in severity and were confined to treatment sites. Treatment-limiting toxic effects were associated with skin irritation and increased with gel exposure. Patients achieved an overall response rate of 63% and a clinical complete response rate of 21%. Median projected time to onset of response was 20.1 weeks (range, 4.0-86.0 weeks), and the estimated median response duration from the start of therapy was 99 weeks. Patients with no previous therapy for mycosis fungoides responded at a higher rate (75%) than those who previously underwent topical therapies (67%). CONCLUSIONS:Bexarotene gel was well tolerated, was easily self-applied, and had a substantial response rate in treating patients with early-stage CTCL.
Authors: Joselin D Tacastacas; Derek V Chan; Sean Carlson; Stanton L Gerson; Afshin Dowlati; Pingfu Fu; Kurt Lu; Sarah Groft; Julie Rosenjack; Kord Honda; Thomas S McCormick; Kevin D Cooper Journal: JAMA Dermatol Date: 2017-05-01 Impact factor: 10.282
Authors: Elma D Baron; Christi L Malbasa; Diana Santo-Domingo; Pingfu Fu; Janine D Miller; Kaija K Hanneman; Andrew H Hsia; Nancy L Oleinick; Valdir C Colussi; Kevin D Cooper Journal: Lasers Surg Med Date: 2010-12 Impact factor: 4.025
Authors: Stuart R Lessin; Madeleine Duvic; Joan Guitart; Amit G Pandya; Bruce E Strober; Elise A Olsen; Christopher M Hull; Elizabeth H Knobler; Alain H Rook; Ellen J Kim; Mark F Naylor; David M Adelson; Alexa B Kimball; Gary S Wood; Uma Sundram; Hong Wu; Youn H Kim Journal: JAMA Dermatol Date: 2013-01 Impact factor: 10.282